title: Waiver of informed consent: a survey of emergency medicine patients.
abstract: Changes to Federal regulations pertaining to waiver of informed consent for acute care research were debated by the research and regulatory communities for more than 2 years before being finalized in October of 1996. Input from the general public was limited. This survey investigated the opinions of emergency medicine patients concerning waiver of informed consent for acute care research. A convenience sample of 212 patients were approached at a tertiary care academic urban emergency department. Seventy-three percent approved of waiver of informed consent if the absolute risks were minimal (50% if the absolute risks were greater than minimal but the incremental risks were minimal). Educational status and certain aspects of the patient's current health status (but not age, race, or gender) significantly affected the results. While most emergency medicine patients would want to be enrolled in a study if they had a serious illness and were unable to give informed consent, a significant percentage of patients would not want to be enrolled regardless of the degree of risk or availability of a family member to speak on their behalf. Waiver of informed consent for emergency research is an ethical dilemma pitting individual rights against societal needs and physician parentalism. A better understanding of what patients consider appropriate may help in resolving this dilemma.
authors.affiliation: Department of Emergency Medicine, Baystate Medical Center, Springfield, MA 01199, USA.
authors.forename: H A
authors.initials: HA
authors.lastname: Smithline
authors.forename: M L
authors.initials: ML
authors.lastname: Gerstle
mesh_terms: D000208:Acute Disease; D003625:Data Collection; D004522:Educational Status; D004635:Emergency Medicine / Q000331:legislation & jurisprudence; D004638:Emergency Treatment; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence*; D010865:Pilot Projects; D011639:Public Opinion; D012106:Research / Q000331:legislation & jurisprudence*; D014481:United States